Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures
NCT ID: NCT00988429
Last Updated: 2021-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
653 participants
INTERVENTIONAL
2008-12-02
2012-01-12
Brief Summary
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Detailed Description
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The first period was an 8 week observation baseline period (Week -8 to Week -1) during which subjects were instructed on how to complete the seizure diary. At the end of the 8 week observational baseline period, eligible subjects were randomized in a 1:1:1 allocation ratio to 1 of 3 treatment groups (with a blinded treatment assignment):
* Placebo
* ESL 800 mg QD
* ESL 1200 mg QD Subjects then entered the second period of Part 1, the 2 week, double blind, up titration period (Week 1 to Week 2). During this period, subjects in the ESL 800 mg group received ESL 400 mg QD, subjects in the ESL 1200 mg group received ESL 800 mg QD, and subjects in the placebo group received placebo QD.
Subjects then entered the third period of Part I, the 12 week, double-blind, maintenance period (Week 3 to Week 14) where subjects in the ESL 800 mg group received ESL 800 mg QD, subjects in the ESL 1200 mg group received ESL 1200 mg QD, and subjects in the placebo group received placebo QD.
At the completion of the maintenance period, subjects who did not enter Part II were to be tapered off study drug while maintaining the blind according to the following down titration procedure: subjects on 800 mg were down titrated to 400 mg for a duration of 2 weeks, and subjects on 1200 mg were down titrated to 800 mg for 1 week and then down-titrated to 400 mg for 1 week and subjects in the placebo group received placebo QD for 2 weeks. During Part I, 1 to 2 concomitant AEDs were allowed in this study and were to be kept stable during the course of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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800 mg QD Eslicarbazepine acetate
tablets
800 mg QD Eslicarbazepine acetate
Oral, 800 mg QD, 2-week titration period and 12-week maintenance period
1200 mg QD Eslicarbazepine acetate
tablets
1200 mg QD Eslicarbazepine acetate
Oral, 1200 mg QD, 2-week titration followed by 12-week maintenance period
Placebo
tablets
Placebo
Placebo tablet given QD
Interventions
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800 mg QD Eslicarbazepine acetate
Oral, 800 mg QD, 2-week titration period and 12-week maintenance period
1200 mg QD Eslicarbazepine acetate
Oral, 1200 mg QD, 2-week titration followed by 12-week maintenance period
Placebo
Placebo tablet given QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Written informed consent signed by patient.
2. Aged 16 years or more (patients under 18 years of age require parental/legal representative consent). In North America as well as in other participating countries, when appropriate and/or required by state or local law, minor patients must give written informed assent prior to participation in the study.
3. A documented diagnosis of epilepsy since at least 12 months prior to screening.
4. At least 4 partial-onset seizures (including subtypes of simple partial, complex partial and partial seizures evolving to secondarily generalised) on the 4 weeks prior to screening.
5. Currently treated with 1 or 2 AEDs (any except OXC), in a stable dose regimen during at least 1 month prior to screening. Patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified (a confirmatory test should be available within 1 month before study entry). The device for VNS should be implanted at least 6 months before screening; parameters need to be stable for at least 1 month prior to screening (VNS will not be counted as concomitant AED).
6. Excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination findings, and clinical laboratory test results.
7. Post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation. In case of women of childbearing potential (WOCBP), patient must present a serum beta-human chorionic gonadotropin (B-hCG) test consistent with a non gravid state and agree to remain abstinent or use reliable contraception (hormonal contraception should be combined with a barrier method) beginning at screening and continuing at least to the PSV.
At V2 (randomisation), patient must have:
8. At least 8 partial-onset seizures during baseline with at least 3 partial-onset seizures in each 4-week section of the 8-week baseline period prior to randomisation (documented in a diary) and no seizure-free interval exceeding 28 consecutive days.
9. In case of WOCBP, patient must present a urine B-hCG test consistent with a non gravid state.
10. Diaries satisfactorily completed by the patient or his/her caregiver.
11. Satisfactorily complied with the study requirements during the baseline period (including no changes in concomitant AED therapy should have occurred in the baseline period).
Exclusion Criteria
1. Only simple partial seizures with no motor symptomatology (classified as A2 4 according to the International Classification of Epileptic Seizures).
2. Primarily generalised seizures.
3. Known progressive neurological disorders (progressive brain disease; epilepsy secondary to progressive cerebral lesion).
4. Occurrence of seizures too close to count accurately.
5. History of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening.
6. Seizures of non-epileptic origin.
7. Seizures of psychogenic origin within the last 2 years.
8. Major psychiatric disorders.
9. Documented diagnosis of schizophrenia with accompanying documented history of at least 1 acute psychosis episode within the last 2 years) or history of suicide attempt.
10. Currently treated with OXC.
11. Using benzodiazepines on more than an occasional basis (defined as more than 2 times per week), except when used chronically as AED.
12. Known exposure to Eslicarbazepine acetate from previous study.
o Previous use of Eslicarbazepine acetate or participation in a clinical study with Eslicarbazepine acetate (patients not exposed to Eslicarbazepine acetate \[e.g., screen failed\] are allowed).
13. Known hypersensitivity to carboxamide derivatives.
14. History of abuse of alcohol, drugs or medications within the last 2 years.
15. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder.
16. Second or third-degree atrioventricular blockade not corrected with a pacemaker.
17. Relevant clinical laboratory abnormalities (e.g., sodium \<130 mmol/L, alanine or aspartate transaminases \>2.0 times the upper limit of the normal, white blood cell \[WBC\] count \<3,000 cells/mm3) or for patients of Asian ancestry, positive HLA B\*1502 test.
18. Estimated creatinine clearance \<60 mL/min \[men: (140-age) x weight/serum creatinine x 72; women: (0.85) (140-age) x weight/serum creatinine x 72. Age in years, weight in kg, and serum creatinine in mg/dL\].
19. Pregnant or nursing.
20. Participation in other drug clinical trial within the last 2 months or received an investigational drug within 5 half-lives of this other product, whichever is longer. Patient(s) who are known to have not taken any doses of study drug(s) in earlier study(ies) (e.g. screen-failures) are allowed without any time limitation.
21. Not ensured capability to perform the trial.
22. Any other condition or circumstance that, in the opinion of the Investigator, may compromise the patient's ability to comply with the study protocol.
23. Currently treated with VNS, but implanted \<6 months before screening or parameters not stable for at least 1 month prior to screening.
At V2 (randomisation), patients must not be/have:
25. Inadequate completion of the study diary.
26. Any other condition or circumstance that, in the opinion of the Investigator, may compromise the patient's ability to comply with the study protocol.
16 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Bial - Portela C S.A.
INDUSTRY
Responsible Party
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Locations
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University of South Alabama Department of Neurology
Mobile, Alabama, United States
Neurology Clinic, P.C.
Northport, Alabama, United States
21st Century Neurology - Division of Xenoscience, Inc.
Phoenix, Arizona, United States
Barrow Neurological Institute / St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Phoenix Neurological Associates/Clinical Research Advantage
Phoenix, Arizona, United States
ANI Research, PC
Sun City, Arizona, United States
University of Arizona Health Sciences Center
Tucson, Arizona, United States
Arkansas Neurology
Conway, Arkansas, United States
Clinical Trials Inc.
Little Rock, Arkansas, United States
Kern County Neurological Medical Group, INC.
Bakersfield, California, United States
Neuro-Pain Medical Center, Inc.
Fresno, California, United States
Loma Linda University
Loma Linda, California, United States
Collaborative Neuroscience Network, INC
Long Beach, California, United States
Viking Clinical Research Center
Murrieta, California, United States
Bright Minds Institute
San Francisco, California, United States
Milestone Clinical Research
San Jose, California, United States
Neurosearch II, Inc.
Ventura, California, United States
University of Colorado Health Sciences
Aurora, Colorado, United States
Denver Health
Denver, Colorado, United States
Bradenton Research Center
Bradenton, Florida, United States
Optima Neurological Services, LLC
Gainesville, Florida, United States
University of Florida Department of Neurology
Gainesville, Florida, United States
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States
Palm Springs Research Institute
Hialeah, Florida, United States
University of Florida
Jacksonville, Florida, United States
Pharmax Research Clinic
Miami, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
University of Miami - Miller School of Medicine Department of Neurology
Miami, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Neuroscience Consultants
Miami, Florida, United States
Kendall South Medical Center, Inc.
Miami, Florida, United States
Medsol Clinical Research Center
Port Charlotte, Florida, United States
Lovelace Scientific Resources
Sarasota, Florida, United States
University of South Florida - Department of Neurology
Tampa, Florida, United States
Pediatric Epilepsy & Neurology Specialists, PA
Tampa, Florida, United States
Lovelace Scientific Resources
Venice, Florida, United States
Palm Beach Clinical Research Network, LLC.
Wellington, Florida, United States
Harbin Clinic
Rome, Georgia, United States
Consultants in Epilepsy and Neurology, PPLC
Boise, Idaho, United States
Southern Ilinois University School of Medicine
Springfield, Illinois, United States
Josephson Wallack Munshower Neurology P.C.
Indianapolis, Indiana, United States
McFarland Clinic, PC
Ames, Iowa, United States
Broadlawns Medical Center
Des Moines, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
LSUHSC Epilepsy Center
New Orleans, Louisiana, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Mid-Atlantic Epilepsy and Sleep Centre
Bethesda, Maryland, United States
MGH Epilepsy Service Massachusetts, General Hospital
Boston, Massachusetts, United States
Wayne State University/Detroit Medical Center
Detroit, Michigan, United States
Minneapolis Clinic of Neurology, Ltd
Golden Valley, Minnesota, United States
Minnesota Epilepsy Group, P.A.
Saint Paul, Minnesota, United States
Precise Research Centers
Flowood, Mississippi, United States
The Comprehensive Epilepsy Care Centre for Chidren and Adults
Chesterfield, Missouri, United States
The Cooper Health System
Camden, New Jersey, United States
Clinical Research Centre of New Jersey
Gibbsboro, New Jersey, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
St. Joseph Regional Medical Center
Paterson, New Jersey, United States
Shore Neurology, PA
Toms River, New Jersey, United States
Albany Medical College - Neurosciences Institute
Albany, New York, United States
Five Towns Neuroscience Research
Cedarhurst, New York, United States
Neurological Care of CNY
Liverpool, New York, United States
Beth Israel Medical Center
New York, New York, United States
NYU Comprehensive Epilepsy Centre
New York, New York, United States
Wiell Cornell Medical Centre Epilepsy Centre
New York, New York, United States
Dent Neurologic Institute
Orchard Park, New York, United States
Strong Epilepsy Center - University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The Neurological Institute, P.A.
Charlotte, North Carolina, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
Wilmington Medical Research
Wilmington, North Carolina, United States
Ohio State University Medical Centre
Columbus, Ohio, United States
Neurology Specialists, Inc
Dayton, Ohio, United States
University of Toledo - Health Science Campus
Toledo, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Tulsa Clinical Reserch
Tulsa, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Comprehensive Epilepsy Center - Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University School of Medicine - Department of Neurology
Philadelphia, Pennsylvania, United States
Childrens Hospital of Pittsburg of UPMC - Division of Child Neurology
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Private Practice of Dr. Edwin Green
Brownwood, Texas, United States
Texas Neurology, PA
Dallas, Texas, United States
Neurology Consultants of Dallas, P.A.
Dallas, Texas, United States
Neurological Clinic of Texas
Dallas, Texas, United States
UTSWMC Department of Neurology, Division of Epilepsy Research
Dallas, Texas, United States
Medistat Clinical Research
DeSoto, Texas, United States
Nemmar Clinical Resources
DeSoto, Texas, United States
Houston Neurology and Sleep Center
Houston, Texas, United States
Innovative Clinical Trials
San Antonio, Texas, United States
Road Runner Research
San Antonio, Texas, United States
Scott and White Memorial Hospital Sherwood and Brindley Foundation
Temple, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
University of Virginia - Comprehensive Epilepsy Program
Charlottesville, Virginia, United States
Sentara Medical Group, Neurology Specialists Sentara Heart Hospital
Norfolk, Virginia, United States
Neurological Associates of Washington/Clinical Trials of America, Inc
Bellevue, Washington, United States
Ranier Clinical Research Center
Renton, Washington, United States
University Washington Regional Epilepsy Center Harborview
Seattle, Washington, United States
MultiCare Adult Neurology
Tacoma, Washington, United States
Dean & St. Mary's Outpatient Center Neurological Institute and Spine Center
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Regional Epilepsy Centre of Aurora Healthcare- St. Luke's Medical Centre
Milwaukee, Wisconsin, United States
Medical College of Wisconsin - Department of Neurology
Milwaukee, Wisconsin, United States
Hospital Privado de la comunidad de Mar de Plata
Buenos Aires, , Argentina
CEMIC
Buenos Aires, , Argentina
Centro Neurológico de Tratamiento y Rehabilitación
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Hospital Ramos Mejía
Capital Federal, , Argentina
Hospital Británico
Capital Federal, , Argentina
Fleni
Capital Federal, , Argentina
Instituto Médico Especializado (IME)
Capital Federal, , Argentina
Hospital Privado - Centro Médico de Córdoba S.A.
Córdoba, , Argentina
Centro de Neurologia y Neurorehabilitacion
Córdoba, , Argentina
Centre Neurologique William Lennox
Ottignies, , Belgium
Clinique Saint-Pierre
Ottignies, , Belgium
AZ. Sint-Augustinus
Wilrijk, , Belgium
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, , Brazil
Hospital das Clínicas - UNICAMP
Campinas, , Brazil
Instituto de Neurologia de Curitiba
Curitiba, , Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, , Brazil
Hospital São Lucas - PUCRS
Porto Alegre, , Brazil
Hospital das Clinicas da FMRP
Ribeirão Preto, , Brazil
Faculdade de Medicina do ABC
Santo André, , Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, , Brazil
Hospital Brigadeiro
São Paulo, , Brazil
Hospital São Paulo - UNIFESP
São Paulo, , Brazil
University of Calgary Clinical Neurosciences
Calgary, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
The Cyprus Institute of Neurology
Nicosia, , Cyprus
CENTRE HOSPITALIER PELLEGRIN, CHU de BORDEAUX
Bordeaux, , France
Hopital Femme-Mere-Enfant, Hospices Civils de Lyon
Bron, , France
Hopital Roger Salengro, Chru de Lille
Lille, , France
Hopital Gui de Chauliac, Chu de Montpellier
Montpellier, , France
Hopital Central, Chu de Nancy
Nancy, , France
Centre Hospitalier Sainte-Anne
Paris, , France
Hopital Pontchaillou, Chru de Rennes
Rennes, , France
Hopital Civil, Chru de Strasbourg
Strasbourg, , France
Epilepsie-Zentrum Berlin Brandenburg am Evangelischen Krankenhaus Königin Elisabeth Herzberge
Berlin, , Germany
Charite, Universitätsmedizin Berlin, CVK
Berlin, , Germany
Universitätsklinikum Essen
Essen, , Germany
Klinik für Neurologie, Klinische Neurophysiologie und Stroke Unit
Munich, , Germany
Klinik und Poliklinik für Neurologie der Universität Regensburg im Bezirksklinikum
Regensburg, , Germany
Evangelismos General Hospital
Athens, , Greece
Agios Loukas (St. Luke's) Hospital
Thessaloniki, , Greece
General Hospital of Thessaloniki "Papanikolaou"
Thessaloniki, , Greece
Azienda Ospedaliero, Universitaria "Ospedali Riuniti", Clinica della Malattie del Sistema Nervoso, Università di Foggia
Foggia, , Italy
A.O.U Policlinico di Messina
Messina, , Italy
Università degli Studi di Napoli Policlinico Federico II
Napoli, , Italy
Azienda Ospedaliero - Universitaria Maggiore della Carità
Novara, , Italy
Istituto Neurologico Casimiro Mondino
Pavia, , Italy
Università Cattolica del Sacro Cuore Policlinico "A. Gemelli"
Roma, , Italy
Azienda Universitatia Ospedaliera San Giovanni Battista
Torino, , Italy
Centrum Neurologii Klinicznej
Krakow, , Poland
NZOZ Polimedica
Lodz, , Poland
Wojewódzki Szpital Specjalistyczny w Lublinie Oddzial Neurologii
Lublin, , Poland
Wojewódzki Szpital Specjalistyczny w Olsztynie, Oddzial Neurologii
Olsztyn, , Poland
NZOZ "NEURO - KARD,"Ilkowski I Partnerzy Spólka, Partnerska Lekarzy
Poznan, , Poland
Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna
Warsaw, , Poland
Countries
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References
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Andermann E, Rosenfeld W, Penovich P, Rogin J, Cendes F, Carreno M, Ramsay RE, Ben-Menachem E, Gama H, Rocha F, Soares-da-Silva P, Tosiello R, Blum D, Grinnell T. Comparative analysis of the safety and tolerability of eslicarbazepine acetate in older (>/=60 years) and younger (18-59 years) adults. Epilepsy Res. 2021 Jan;169:106478. doi: 10.1016/j.eplepsyres.2020.106478. Epub 2020 Oct 10.
Cramer JA, Colman S, Anastassopoulos KP, Grinnell T, Mehta D, Williams GR. Associations between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life in patients with focal seizures treated with adjunctive eslicarbazepine acetate: Post hoc analyses of clinical trial results. Epilepsy Behav. 2020 Nov;112:107312. doi: 10.1016/j.yebeh.2020.107312. Epub 2020 Aug 12.
Other Identifiers
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2008-002455-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BIA-2093-304
Identifier Type: -
Identifier Source: org_study_id
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